A Study of the efficacy and safety of Rizatriptan 10 mg PRD in the treatment of acute migraine in patients with non satisfactory response to previous pharmacologic treatment - Rinotama Study
- Conditions
- acute migraine
- Registration Number
- EUCTR2006-000799-33-DE
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
Subjects must fulfill the following conditions to qualifiy for enrollment into the trial:
4.1.1 18 to 65 years of age, both genders.
4.1.2 Willingness to comply with the investigators and protocol's instructions.
4.1.3 patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form].
4.1.4 have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
4.1.5 At screening at least two migraine attacks per month and no more than ten during the last three months prior to inclusion.
4.1.6 At screening a stable dose of prophylactic medication (including no prophylactic treatment) for at least two months and no change of prophylactic medication during active trial period.
4.1.7 Safe method of contraception. Oral contraception, double barrier method, IUP is considered safe as well as no active sexual behavior.
Reliable means of birth control is defined as:
a) Female sterilization; or
b) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post menopausal (>1 year since last menstrual cycle); or
c) Male partner(s) who is (are) sterile prior to the female subject´s entry into the study and is (are) the sole sexual partner(s) for that female subject; or
d) Implants of levonorgestral within the lifetime of the implant; or
e) Injectable progesterone; or
f) Oral contraception (combined or progestogen only) started at least 2 months
prior entry in the study; or
g) Any intrauterine device (IUD) with published data showing that the highest expectedfailure rate is less than 1% per year; or
h) Double barrier contraception (e.g., combination of physical and chemical methods,
preferably a spermicide with either a condom or a diaphragm); or
i) Any other method of contraception with data documented in the product labeling as approved by regulatory agencies, or in the absence of approved labeling, in peer
reviewed studies, showing that the highest expected failure rate for that method is
less than 1% per year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
patients with any of the following coonditions may not be enrolled into the trial:
4.2.1 Contraindication to triptans or Rizatriptan according to medical information sheet.
4.2.2. Patient has a history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease. Patient has uncontrolled hypertension. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to Rizatriptan or any of its inactive ingredients.
4.2.3 History of treatment failure for more than one triptan for the treatment of acute migraine attacks.
4.2.4 Medical relevant diagnosis of internal, neurological or psychiatric disease.
4.2.5 Any other headache, except tension type headache on 5 or less days a month within three months prior to screening.
4.2.6 A history of drug induced headache, medication overuse headache or any other addiction.
4.2.7 Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial.
4.2.8Females of childbearing potential not using reliable means of birth control, pregnant or lactating females or expected/ planned pregnancy.
4.2.9. Participation (planned or current) in any investigational drug or device trial within the previous 30 days prior to screening visit.
4.2.10. Inability to understand the trial procedures, and thus inability to give informed consent.
unwillinglingness to accept the risk of of participating in the trial
4.2.11 History of allergy to sulfa drugs
4.2.12 Patient is pregnant or a nursing mother
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Headache response measured on a one to four point scale (Glaxo scale) two hours after intake of Rizatriptan 10 mg RPD;Secondary Objective: Percentage of patients being headache free two hours after intake of study medication. Time of dosing to onset of headache relieve measured by stopwatch.<br>Time of dosing to return to work/ social function (time points 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours after drug intake).<br>Relief of concomitant symptoms.<br>Need of rescue medication.<br>Percentage of patients with sustained pain relief (Improvement of pain from severe or moderate to mild or no headache without recurrence and need of rescue medication for the next 22 hours).<br>;Primary end point(s): evaluate the efficacy of Rizatriptan in the treatment of acute migraine attacks in patients with documented self-reported unsatisfactory response to analgesics and / or one triptan prior to enrollment
- Secondary Outcome Measures
Name Time Method